510(k) K840402
K840402 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "AUDIO BANDWIDTH ANALYZER". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1984
- Date Received
- January 31, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type